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Date: Saturday, January 23, 2021 16:34

Release 3.181
Simparica Trio chewable tablets for dogs
 
Species: Dogs
Therapeutic indication: Pharmaceuticals: Endectocides: For companion animals
Active ingredient: Moxidectin, Pyrantel Embonate, Sarolaner
Product:Simparica Trio chewable tablets for dogs
Product index: Simparica Trio
Presentation
Simparica Trio chewable tablets are a reddish brown, pentagon shaped tablet with rounded edges. Tablets are debossed with the sarolaner strength on one face. Each tablet contains:
Simparica Trio chewable tablets
sarolaner (mg)
moxidectin (mg)
pyrantel (as embonate) (mg)
for dogs 1.25 - 2.5 kg
3
0.06
12.5
for dogs >2.5 - 5 kg
6
0.12
25
for dogs >5 - 10 kg
12
0.24
50
for dogs >10 - 20 kg
24
0.48
100
for dogs >20 - 40 kg
48
0.96
200
for dogs >40 - 60 kg
72
1.44
300
Uses
For the treatment of dogs with, or at risk from, mixed external and internal parasitic infestations. Simparica Trio is exclusively indicated when use against ticks or fleas and gastrointestinal nematodes is indicated at the same time. The veterinary medicinal product also provides concurrent efficacy for the prevention of heartworm disease and angiostrongylosis.
Ectoparasites
For the treatment of tick infestations. The veterinary medicinal product has immediate and persistent tick killing activity for 5 weeks against Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus and for 4 weeks against Dermacentor reticulatus;
For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis). The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for 5 weeks;
The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Gastrointestinal nematodes
For the treatment of gastrointestinal roundworm and hookworm infections:
Toxocara canis immature adults (L5) and adults;
Ancylostoma caninum L4 larvae, immature adults (L5) and adults;
Toxascaris leonina adults;
Uncinaria stenocephala adults.
Other nematodes
For the prevention of heartworm disease (Dirofilaria immitis);
For the prevention of angiostrongylosis by reducing the level of infection with immature adult (L5) stages of Angiostrongylus vasorum.
Dosage and administration
For oral use.
Simparica Trio should be administered at a dose of 1.2-2.4 mg/kg of sarolaner, 0.024-0.048 mg/kg moxidectin and 5-10 mg/kg of pyrantel in accordance with the following table.
Method of administration
Tablets can be administered with or without food.
Simparica Trio tablets are palatable and readily consumed by the majority of dogs when offered by the owner. If the tablet is not taken up voluntarily by the dog it can also be given with food or directly into the mouth. The tablets should not be divided.
Bodyweight (kg)
Tablet strength 3 mg/0.06 mg/12.5 mg
Tablet strength 6 mg/0.12 mg/25 mg
Tablet strength 12 mg/0.24 mg/50 mg
Tablet strength 24 mg/0.48 mg/100 mg
Tablet strength 48 mg/0.96 mg/200 mg
Tablet strength 72 mg/1.44 mg/300 mg
1.25 -2.5
1
>2.5 - 5
1
>5 - 10
1
>10 - 20
1
>20 - 40
1
>40 - 60
1
>60
Appropriate combination of tablets
Treatment schedule:
The treatment schedule should be based on veterinary diagnosis, the local epidemiological situation and/or the epidemiological situation of other areas the dog has visited or is going to visit. If based on veterinarian opinion re-administration(s) of the product is required, any subsequent administration(s) must follow the minimum 1 month interval schedule.
The product should only be used in dogs when treatment of ticks / fleas and gastrointestinal nematodes is indicated at the same time. In the absence of the risk of mixed co-infestation, a narrower spectrum parasiticide should be used.
Treatment of flea and tick infestations and gastrointestinal nematodes:
The veterinary medicinal product can be used as part of the seasonal treatment of fleas and ticks (replacing treatment with a mono-active flea and tick product) in dogs with diagnosed concurrent gastrointestinal nematode infections. A single treatment is efficacious for the treatment of gastrointestinal nematodes. After treatment of the nematode infections, further flea and tick treatment should be continued with a mono-active product.
Prevention of heartworm disease and angiostrongylosis:
A single administration also prevents lungworm disease (by reducing the immature adults (L5) of A. vasorum) and heartworm disease (D. immitis) for one month. When the product replaces another lungworm or heartworm preventive product, the first dose of the product should be given within a month of the last dose of the former veterinary medicinal product. In endemic areas, dogs should receive lungworm and/or heartworm preventive treatments at monthly intervals. It is recommended that heartworm prevention treatment should be continued until at least 1 month after the last exposure to mosquitoes.
Contra-indications, warnings, etc
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Ticks and fleas need to start feeding on the host to become exposed to sarolaner; therefore, the transmission of infectious parasite-borne diseases cannot be excluded.
This veterinary medicinal product is not effective against adult D. immitis. However, accidental administration to dogs infected with adult heartworms should not pose safety concerns. Dogs in areas endemic for heartworm (or those which have travelled to endemic areas) may be infected with adult heartworms. Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control. To minimise the risk of resistance selection, it is recommended that dogs should be checked for both circulating antigens and blood microfilariae at the beginning of each season of preventative treatment. Only negative animals should be treated.
Parasite resistance to any particular class of parasiticides may develop following the frequent, repeated use of a product of that class. Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.
In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 1.25 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
The product was well tolerated in dogs with a deficient multidrug-resistance-protein 1 (MDR1 -/-). However, in such sensitive breeds (which may include, but not necessarily limited to, Collies and related breeds), the recommended dose should be strictly observed.
The safety of Simparica Trio has not been established during pregnancy and lactation or in dogs intended for breeding. The use in these animals is not recommended.
User warnings:
Wash hands after handling the product.
The accidental ingestion of the product may potentially result in adverse effects, such as transient excitatory neurological signs. To prevent children from accessing the product, only one chewable tablet at a time should be removed from the blister pack and only when required. The blister pack should then be returned into the carton immediately after use and the carton should be stored out of the sight and reach of children. In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
Pharmaceutical precautions
Store below 30°C.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Keep out of the sight and reach of children.
For animal treatment only.
Legal category
Legal category: POM-V
Packaging quantities
Supplied in cartons containing 1, 3 or 6 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder (if different from distributor)
Further information
Ticks on the animal prior to administration or from new infestations after product administration are killed within 48 hours.
For fleas, the onset of efficacy is within 12 to 24 hours of attachment for five weeks after product administration. Fleas on the animal prior to administration are killed within 8 hours. The veterinary medicinal product kills newly emerged fleas on the dog before they can lay eggs and therefore it prevents environmental flea contamination in areas to which the dog has access.
Sarolaner is an acaricide and insecticide belonging to the isoxazoline family. The primary target of action of sarolaner in insects and acarines is functional blockade of ligand-gated chloride channels (GABA-receptors and glutamate-receptors). Sarolaner blocks GABA- and glutamate-gated chloride channels in the central nervous system of insects and acarines. Sarolaner is active against adult fleas (Ctenocephalides felis and Ctenocephalides canis) as well as several tick species such as Dermacentor reticulatus, Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus.
Moxidectin is a second generation macrocyclic lactone of the milbemycin family. Its principal mode of action is interfering with neuromuscular transmission at the level of the glutamate-gated chloride channels and, to a lesser extent, of GABA (gamma amino butyric acid)-gated channels. This interference leads to the opening of the chloride channels on the postsynaptic junction to allow the inflow of chloride ions. This results in flaccid paralysis and eventual death of parasites exposed to the drug. Moxidectin is active against adults of Toxocara canis, L4 larvae and immature stages (L5) of Ancylostoma caninum, L4 of Dirofilaria immitis and immature stages (L5) of Angiostrongylus vasorum.
Pyrantel is a nicotinic acetylcholine (ACh) channel receptor (nAChR) agonist. Pyrantel mimics the agonist effects of ACh through high affinity binding to subtype specific ionophoric nAChRs in nematodes, while not binding at muscarinic mAChRs. Following receptor binding, the channel opens to allow the influx of cations resulting in a depolarization and excitatory effects on nematode muscle, ultimately leading to spastic paralysis of the worm and death. Pyrantel is active against immature stages (L5) and adults of Toxocara canis, adults of Ancylostoma caninum, Toxascaris leonina and Uncinaria stenocephala.
In this fixed combination, moxidectin and pyrantel provide complementary anthelmintic efficacy through distinct mechanisms of action. In particular, both active substances contribute to the overall efficacy against the gastrointestinal nematodes Ancylostoma caninum and Toxocara canis.
No adverse reactions were observed in 8-weeks old healthy puppies administered with up to 5 times the maximum recommended dose for 7 consecutive monthly administrations.
In a laboratory study, the product was well tolerated in dogs with a deficient multidrug-resistance-protein 1 (MDR1 -/-) following single oral administration at 3 times the recommended dose. After a single administration of 5 times the maximum recommended dose to this sensitive dog breed, transient ataxia and/or muscle fasciculation were observed.
Macrocyclic lactones including moxidectin have been shown to be substrates for p-glycoprotein. Therefore, during treatment with the veterinary medicinal product, other products that can inhibit p-glycoprotein (e.g. cyclosporine, ketoconazole, spinosad, verapamil) should only be used concomitantly according to the benefit-risk assessment of the responsible veterinarian.
Marketing Authorisation Number
EU/2/19/243/001-018
Significant changes
GTIN
GTIN description:1.25 - 2.5 kg 3 pack
GTIN:05414736044828
GTIN description:1.25 - 2.5 kg 6 pack
GTIN:05414736044880
GTIN description:2.5 - 5 kg 3 pack
GTIN:05414736044835
GTIN description:2.5 - 5 kg 6 pack
GTIN:05414736044897
GTIN description:5 - 10 kg 3 pack
GTIN:05414736044842
GTIN description:5 - 10 kg 6 pack
GTIN:05414736044903
GTIN description:10 - 20 kg 3 pack
GTIN:05414736044859
GTIN description:10 - 20 kg 6 pack
GTIN:05414736044927
GTIN description:20 - 40 kg 3 pack
GTIN:05414736044866
GTIN description:20 - 40 kg 6 pack
GTIN:05414736044910
GTIN description:40 - 60 kg 3 pack
GTIN:05414736044873
GTIN description:40 - 60 kg 6 pack
GTIN:05414736044934